(401 days)
The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.
The Sunmed™ High Pressure Line is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.
The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.
The Sunmed™ High Pressure Line is single use and supplied sterile by Ethylene Oxide.
Package: Material: Dupont Tyvek package for medical use.
This document is a 510(k) premarket notification for a medical device called the "Sunmed™ High Pressure Line." It seeks to demonstrate substantial equivalence to previously marketed predicate devices, rather than establishing de novo acceptance criteria and proving performance through a clinical study. Therefore, much of the requested information about acceptance criteria for a novel device and specific study types (like MRMC or standalone performance) is not applicable or present in this filing.
However, I can extract the relevant information regarding the non-clinical testing performed to support substantial equivalence.
Here's a breakdown based on your request, explaining why some sections are not applicable to this type of regulatory submission:
Acceptance Criteria and Device Performance (Non-Clinical)
Since this is a 510(k) submission, the "acceptance criteria" are primarily established by demonstrating the device performs comparably to legally marketed predicate devices, especially through non-clinical testing. The "reported device performance" refers to the successful completion of these non-clinical tests.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (Successful Testing) |
|---|---|
| Biocompatibility: | |
| - Absence of pyrogenic response | Pyrogen Test: Passed |
| - Absence of acute systemic toxicity | Acute Systemic Toxicity Test: Passed |
| - Absence of intracutaneous reactivity | Intracutaneous Reactivity Test: Passed |
| - Absence of in vitro cytotoxicity | In Vitro Cytotoxicity Test: Passed |
| - Absence of skin sensitization | Skin sensitization Test (two kinds of solvent): Passed |
| - Acceptable hemolytic response | In Vitro Hemolysis Study (ASTM F756-08): Passed |
| Material/Device Integrity: | |
| - Resistance to aging effects | Aging Testing: Passed |
| - Mechanical/functional integrity | Bench Testing: Passed |
| Sterility: | |
| - Maintenance of sterile barrier | Package Penetrate Testing: Passed |
| - Sterility assurance | Asepsis Testing: Passed |
| - Acceptable residual levels | EtO and ECH Residue Testing: Passed |
| Equivalence in Technological Characteristics | |
| - Intended use, materials, fundamental scientific technology, operating principle, sterility assurance level, method of sterilization equivalent to predicate devices. | Detailed comparison provided, concluding identical technological characteristics. |
Study Details
Given this is a 510(k) for a device like a high-pressure line, the "study" is primarily a non-clinical bench and lab testing program designed to demonstrate substantial equivalence, not a clinical trial.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each non-clinical test. These tests typically use a defined number of device units as per specific test standards (e.g., ISO or ASTM standards).
- Data Provenance: The tests were performed by or for Sunny Medical Device (Shenzhen) Co., Ltd. The physical location of testing is not specified beyond the company's address in Shenzhen, China. This would be considered retrospective data in the context of this submission, as the tests were completed prior to the FDA review.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable for this type of non-clinical device testing. "Ground truth" and expert consensus are concepts typically applied to diagnostic algorithms or subjective assessments in clinical settings. Here, "ground truth" is defined by adherence to established testing standards and objective measurements (e.g., passing a sterility test or showing no toxicity).
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Adjudication method for the test set:
- Not applicable. Adjudication relates to resolving discrepancies in human expert opinions, which isn't part of non-clinical bench testing. The results of these tests are objective measurements against predefined acceptance criteria from standards.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a passive high-pressure line, not an AI-powered diagnostic tool. Therefore, an MRMC study is irrelevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. There is no "algorithm" in this device. Its performance is mechanical and biocompatibility-based.
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The type of ground truth used:
- For the non-clinical tests, the "ground truth" is established by objective scientific standards and measurements (e.g., absence of bacterial growth, specific chemical residue levels, lack of a toxic response in biological assays, structural integrity under pressure). It's not based on expert consensus, pathology, or outcomes data in the traditional sense, but adherence to recognized test methodologies and their pass/fail criteria.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" as it's not an AI/machine learning product. Performance is based on physical and biological testing of manufactured units.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).